Healthcare Industry News:  Black Triangle Drug 

Biopharmaceuticals Urology

 News Release - August 28, 2008

New Treatment Launched to Help Improve Symptoms in People Suffering From Overactive Bladder

LONDON, August 28 (HSMN NewsFeed) -- Pfizer Limited has launched Toviaz®(Black Triangle Drug) (fesoterodine fumarate), a new once daily treatment for the symptoms of overactive bladder (OAB). OAB is a condition which affects an estimated 4.9 million people in the UK(1) (more than twice the number of people with diabetes(2)) and has been shown to have a serious and detrimental effect on people's emotional, psychological and sexual wellbeing(3).

Fesoterodine is an antimuscarinic drug which works by relaxing the muscles found in the wall of the bladder, decreasing sudden uncontrollable bladder contractions and increasing bladder capacity.(4) In two 12 week long, international clinical trials, fesoterodine significantly improved the symptoms of OAB compared to placebo(5),(6) (at least three quarters of patients said their condition improved or greatly improved on the medicine compared with 53% on placebo)(5) and patients taking fesoterodine also showed significant and consistent improvement in health related quality of life (HRQL) compared to placebo(7). This is important as OAB has a significant impact on quality of life, often causing sufferers to stop many of the social and physical activities they previously enjoyed and preventing them from leading a 'normal' life(3).

Fesoterodine is available as a 4 mg and 8 mg prolonged-release tablet(8). In trials, initial treatment effect was seen as early as two weeks after the start of therapy with fesoterodine. In addition, the medicine was generally well tolerated(9). Dry mouth was the most commonly reported adverse event(5),(6).

Overactive bladder occurs when the detrusor muscle that controls emptying of the bladder contracts involuntarily, creating a strong, sometimes uncontrollable urge to urinate. Key symptoms include frequency (needing to pass water more than eight times per day); urgency (the sudden desire to pass urine), and sometimes urge incontinence (leaking or wetting oneself due to complete or partial loss of bladder control)(10). People with an overactive bladder may pass urine as often as 12 times a day or more(5).

OAB can cause significant emotional, psychological and physical problems(3). Yet 40% of people with OAB never seek medical help, usually because they believe that it is an inevitable part of ageing and that no effective treatment is available(10). Lesley Woolnough, Executive Director of Incontact, the UK advocacy charity for people living with bladder and bowel control problems, said "We welcome any new treatment that comes to the market that may potentially improve the quality of life for people living with overactive bladder."

Karen Logan, Nurse Consultant and head of Continence Services for Gwent NHS Healthcare Trust said "Incontinence still has a huge stigma attached to it and many patients feel isolated and suffer in silence with it for many years. As healthcare professionals we need to challenge the stigma and consider new ways of raising awareness and encouraging patients to seek help and take control of their condition."

Notes to editors

- During phase III studies with Toviaz®, the King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) were used to determine health related quality of life. The KHQ comprises nine domains and assesses the impact of incontinence on physical and emotional wellbeing. Scores range from 0 (best) to 100 (worst). The ICIQ-SF assesses urinary frequency and urinary leakage and the effects on daily life and scores range from 0 (low bother) to 21 (maximum bother).

- Incontact is the leading UK advocacy charity which campaigns for people living with bladder & bowel control problems. Dedicated to raising awareness and improving the understanding of continence issues, they provide user-friendly booklets and fact sheets, offer an on-line support forum, a specialist nurse and counsellor helpline and a magazine three times a year. Call confidentially on +44(0)1536-533255, email or visit Registered charity number 1085095.

About Pfizer:

Pfizer Inc, the world's largest research-based pharmaceutical company, discovers, develops, manufactures and markets prescription medicines in 11 therapeutic areas including oncology, cardiovascular, pain, neuroscience and infectious diseases, including HIV/AIDS. Pfizer is also the world's largest animal health company.

Pfizer Inc employs approximately 90,000 colleagues worldwide, all of whom are devoted to working for a healthier world. Pfizer conducts more biomedical research than any other organisation, and has 12,000 professionals working in six major R&D sites worldwide, including Sandwich in Kent. Pfizer's annual UK R&D investment is more than GBP550 million - more than GBP10 million a week.

In the UK, Pfizer has its European R&D headquarters at Sandwich and its UK business headquarters in Surrey, and is the major supplier of medicines to the NHS.


1. Milsom I, Irwin DE, Kelleher C, Reilly K, Bridge SM. Prevalence of urinary incontinence and overactive bladder: UK results from the EPIC study. (Abstract 337). Int Urogynecol J 2006; 17 (Suppl. 2): S57-S100

2. Diabetes: State of the Nations 2006. Progress made in delivering the national diabetes frameworks. A report from Diabetes UK.

3. Nitti V W. Clinical impact of overactive bladder. Rev Urol. 2002;4(suppl 4):S2-S6

4. BNF 55. March 2008

5. Chapple C, Van Kerrebroeck P, Tubaro A et al. Clinical efficacy, safety and tolerability of once-daily fesoterodine in subjects with overactive bladder. European Urol 2007;52:1204-1212

6. Nitti V, Dmochowski R, Sand PK et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol 2007;178:2488-2494

7. Tubaro A, Wang J, Kopp Z, Bavendam T. Improvements in health-related quality of life with fesoterodine in subjects with overactive bladder: pooled data from two randomised controlled studies. ICS 2007. Abstract 462.

8. Summary of Product Characteristics: Toviaz 4 mg & 8 mg prolonged-release tablets

9. Khullar V, Rovner ES, Dmochowski R et al. Fesoterodine dose response in subjects with overactive bladder syndrome. Urol 2008;71:839-843

10. Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001;87(9):760-766.

Source: Pfizer

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